Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 5:16 PM
Study NCT ID:
NCT04944160
Status:
COMPLETED
Last Update Posted:
2022-05-02
First Post:
2021-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the Covid-19 on Respiratory Syncytial Virus (RSV) Epidemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of the number of children hospitalized for a RSV-infection during pre and post-Covid-19 pandemic RSV-winter-epidemic.', 'timeFrame': '2019-2020-winter-epidemic and 2020-2021-winter-epidemic are assessed during June and July, 2021.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bronchiolitis', 'Asthma', 'Pneumonia'], 'conditions': ['RSV Infection']}, 'referencesModule': {'references': [{'pmid': '34296674', 'type': 'DERIVED', 'citation': 'Casalegno JS, Ploin D, Cantais A, Masson E, Bard E, Valette M, Fanget R, Targe SC, Myar-Dury AF, Doret-Dion M, Massoud M, Queromes G, Vanhems P, Claris O, Butin M, Pillet S, Ader F, Bin S, Gaymard A, Lina B, Morfin F; VRS study group in Lyon; Javouhey E, Gillet Y. Characteristics of the delayed respiratory syncytial virus epidemic, 2020/2021, Rhone Loire, France. Euro Surveill. 2021 Jul;26(29):2100630. doi: 10.2807/1560-7917.ES.2021.26.29.2100630.'}]}, 'descriptionModule': {'briefSummary': 'The magnitude of seasonal Respiratory Syncytial Virus (RSV) epidemics brings each year new logistical challenges for the hospitalization of young infants with bronchiolitis that overwhelm hospital capacities and lead to specific winter plans with deprogramming and mobilization of human and logistical resources. The Covid-19 pandemic has changed the way winter epidemics are presented. For example, the seasonal RSV epidemic was shifted by several months in Lyon, with an impression of a lower incidence of hospitalized cases, with a population of older children and with fewer signs of clinical severity. This is largely attributable to the widespread use of barrier gestures and social distancing measures, known as "Non-Pharmacological Interventions" (NPI). Given the magnitude of the reduction of the RSV epidemic, it is legitimate to analyze the benefits of NPIs to draw lessons for maintaining preventive measures around RSV-vulnerable populations; moreover, new preventive pharmacological interventions are soon to be marketed, whether they are particularly refined and long half-life anti-RSV monoclonal antibodies, RSV vaccines for mothers or for newborns and infants. In this perspective, it is crucial to properly define the populations at risk of severe disease to establish a legitimate hierarchy in the implementation of different preventive strategies. The study of the RSV epidemic is a high potential model because of the convergence of epidemiological, virological, and pharmacological knowledge. However, the study of the impact of the pandemic on the epidemiology of rhinovirus also seems promising because, for reasons unknown to date, it seems that the pandemic did not have the same reducing impact on the rhinovirus epidemic; in the latter case, the interest is to confirm the resistance of this virus and to look for more fundamental explanations, for example, on viral interactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France with viral respiratory infection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Child hospitalized at " Hôpital Femme Mère Enfant ", Lyon, France\n\n * Polymerase Chain Reaction (PCR) positive at Respiratory Syncytial Virus (RSV)\n\nExclusion Criteria:\n\n* • Parent\'s refusal to participate'}, 'identificationModule': {'nctId': 'NCT04944160', 'acronym': 'IPCoVRS', 'briefTitle': 'Impact of the Covid-19 on Respiratory Syncytial Virus (RSV) Epidemic', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Impact of the Covid-19 Pandemic on the Epidemiology of Respiratory Syncytial Virus', 'orgStudyIdInfo': {'id': '502'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre Covid-19 cohort', 'description': 'Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a reverse transcriptase - polymerase chain reaction (RT-PCR) positive for Respiratory Syncytial Virus (RSV) during the 2019-2020 winter epidemic', 'interventionNames': ['Other: Medical records analysis', 'Other: Comparison of cohorts']}, {'label': 'Post Covid-19 cohort', 'description': 'Children hospitalized in the Pediatric Department of the " Hôpital Femme Mère Enfant ", Lyon, France with a reverse transcriptase - polymerase chain reaction (RT-PCR) positive for Respiratory Syncytial Virus (RSV) during the 2020-2021 winter epidemic', 'interventionNames': ['Other: Medical records analysis', 'Other: Comparison of cohorts']}], 'interventions': [{'name': 'Medical records analysis', 'type': 'OTHER', 'description': 'To review of medical records to describe diagnosis and severity of the disease.', 'armGroupLabels': ['Post Covid-19 cohort', 'Pre Covid-19 cohort']}, {'name': 'Comparison of cohorts', 'type': 'OTHER', 'otherNames': ['Epidemiology'], 'description': 'To compare pre and post Covid-19 epidemics in terms of numbers of admissions, and proportion of severe disease.', 'armGroupLabels': ['Post Covid-19 cohort', 'Pre Covid-19 cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Groupement Hospitalier EST - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}